NCT04533542

Brief Summary

This trial aims to develop reliable and valid measures of sensory experiences unique to e-cigarette use. Regardless of whether flavorings show evidence of toxicity in a biological sense, they may nonetheless increase harm by other means, such as increasing appeal, decreasing risk perceptions, or masking harshness or irritation that might lead users to discontinue use.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 25, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 31, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

March 10, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 7, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 7, 2023

Completed
Last Updated

April 5, 2024

Status Verified

April 1, 2024

Enrollment Period

2 years

First QC Date

August 25, 2020

Last Update Submit

April 3, 2024

Conditions

Substance-Related Disorder

Outcome Measures

Primary Outcomes (2)

  • Sensory response measures

    Will be assessed by product evaluation scale - Scale consists of 22 questions with #1 = Not at all - 7 = Extremely

    2 years

  • Sensory response measure

    gMLS rating of harshness, throat hit, and pleasantness.

    2 years

Study Arms (2)

Arm I (3 video or telephone conferences)

Participants attend up to 3 video or telephone conferences over 2 hours each with a minimum of 24 hours and maximum of 1 week between sessions. Participants take a fixed number of puffs on 3 randomly assigned conditions (combinations of carrier and nicotine concentrations).

Other: MeasurementOther: Questionnaire Administration

Arm II (2 video or telephone conferences)

Participants attend up to 2 video or telephone conferences over 2 hours each with a minimum of 24 hours and maximum of 1 week between sessions. Participants take a fixed number of puffs on a nicotine-free condition and 3 randomly assigned conditions (combinations of carrier concentration and nicotine form).

Other: MeasurementOther: Questionnaire Administration

Interventions

MeasurementOTHER

Undergo sensory measurements

Also known as: Measure, {Measure}
Arm I (3 video or telephone conferences)Arm II (2 video or telephone conferences)
Questionnaire AdministrationOTHER

Ancillary studies

Arm I (3 video or telephone conferences)Arm II (2 video or telephone conferences)

Eligibility Criteria

Age21 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Participants from general population in the greater Buffalo area and are current daily vapers

You may qualify if:

  • Current daily vapers of products containing nicotine
  • No concurrent use of other tobacco products
  • Self reported general good health
  • No allergies - specifically known active untreated seasonal allergies that would interfere with smell or taste procedures
  • No self-reported taste or smell deficits
  • Not pregnant or lactating
  • No medications known to interfere with taste/smell (i.e.: certain nasal sprays, nasal antihistamines, decongestants, antibiotics, medications containing zinc)
  • Passing scores on the phenylthiocarbamine (PTC) and 6-n-propylthiouracil (PROP) smell and taste tests
  • Access to video-conference or telephone
  • Ability to store test products in a secure location away from children

You may not qualify if:

  • Not current daily vapers
  • Concurrent use of other tobacco products
  • Self-reported fair or poor general health
  • Allergies - active untreated seasonal allergies that would interfere with smell or taste procedures
  • Self-reported taste or smell deficits
  • Pregnant or lactating
  • Medications known to interfere with taste/smell (i.e.: certain nasal sprays, nasal antihistamines, decongestants, antibiotics, medications containing zinc)
  • Failing scores on the phenylthiocarbamine (PTC) and 6-n-propylthiouracil (PROP) smell and taste tests
  • No access to video-conference or telephone
  • Unable to store test products in a secure location away from children
  • Individuals who are not yet adults (infants, children, teenagers)
  • Pregnant women
  • Prisoners
  • Adults unable to consent
  • Adults unable to legally purchase tobacco products in New York (NY) state (18-20)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Weights and Measures

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Richard J O'Connor

    Roswell Park Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2020

First Posted

August 31, 2020

Study Start

March 10, 2021

Primary Completion

March 7, 2023

Study Completion

March 7, 2023

Last Updated

April 5, 2024

Record last verified: 2024-04

Locations

US(1)